Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77896-001-02, 77896-001-04, 77896-001-05, 77896-001-08, view more77896-001-12, 77896-001-16, 77896-001-28, 77896-001-34, 77896-001-64 - Packager: Beyond Borders Intl
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 25, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- INDICATIONS & USAGE
- Directions
- Warnings
- Other Information
- Inactive Ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77896-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALOE VERA LEAF (UNII: ZY81Z83H0X) TROLAMINE (UNII: 9O3K93S3TK) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77896-001-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 2 NDC:77896-001-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 3 NDC:77896-001-05 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 4 NDC:77896-001-08 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 5 NDC:77896-001-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 6 NDC:77896-001-34 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 7 NDC:77896-001-64 1893 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 8 NDC:77896-001-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2020 9 NDC:77896-001-12 360 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/29/2020 Labeler - Beyond Borders Intl (027397675) Establishment Name Address ID/FEI Business Operations Industrias Chamer Sa De Cv 850602483 MANUFACTURE(77896-001)
